To compare the total exposure of CB7630 administered in capsule formulation with that in tablet formulation in patients with prostate cancer under fasted and fed conditions

Inclusion Criteria:

• Willing and able to provide written informed consent
• Written Authorization for Use and Release of Health and Research Study Information (USA sites only) or Data Protection Consent (European sites only) has been obtained.
• Age ≥ 18 years and male
• Histologically, cytologically, or biochemically confirmed adenocarcinoma of the prostate
• Serum potassium ≥ 3.5 mmol/L
• Eastern Cooperative Oncology Group (ECOG) Performance Status of < 2 (Karnofsky Performance Status ≥ 50%)
• No history of adrenal insufficiency or hyperaldosteronism
• Any acute toxicities of prior chemotherapy, radiotherapy have resolved to a NCI CTCAE (version 3) grade of ≤ 1. Chemotherapy induced alopecia and grade 2 neuropathy are excluded from this consideration.
• No radiotherapy, chemotherapy or immunotherapy within 30 days of administration of the SD1 on Day 1.
• No surgery or local prostatic intervention within 28 days of the first dose. In addition, any clinically relevant sequelae from the surgery must have resolved prior to SD1 on Day 1.
• Life expectancy > 12 weeks
• Able to swallow the CB7630 whole as a capsule or tablet
• Able to follow study instructions, accessible for treatment and follow-up, and likely to complete all study requirements.

Exclusion Criteria:

• Active or uncontrolled autoimmune disease that may require corticosteroid therapy
• Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection.
• Uncontrolled hypertension
• Hemoglobin ≤ 9.0 g/dL

• Abnormal liver function tests consisting of any of the following:

  • Serum bilirubin > 1.5 x ULN
  • ALT > 2.5 x ULN
  • AST > 2.5 x ULN
• Serum creatinine > 2.0 x ULN or a calculated creatinine clearance < 50 mL/min
• Clinically significant heart disease as evidenced by a myocardial infarction in the past twelve months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease. Patients with a history of atherosclerotic vascular disease requiring coronary or peripheral artery bypass surgery may be enrolled provided the surgery occurred at least two years prior to enrollment and after consultation with a cardiologist to insure that the disease is stable.
• Other malignancy within the previous 5-years other than basal cell or squamous cell carcinomas of skin with a > 30% probability of recurrence within 12 months.
• History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study medication.
• Current enrollment in an investigational drug or device study or participation in such a study within 30 days of Day 1
• Condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study.